Senior Manager, Regional Clinical Trial Manager

  • Contract
  • Japan

Genmab

ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。

The Role:

Clinical Trial Manager to be part of our Clinical Operation team.

This position is based in our Tokyo office.

As Clinical Trial Manager, you will be part of a dedicated team local and global team and will be operationally responsible for the planning, start-up, conduct and closure of clinical trials in Japan constitute with your knowledge and experience.

It works closely together with the global Clinical Trial Managers with the oversight activities across Genmab clinical trials in Japan, as applicable.

Responsabilities:

Key responsibilities include but are not limited to:

  • Co-leads and/or support the cross-functional Japan trial-specific Clinical Management Team (CMT), including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs, Japan Good Clinical Practice guidelines and ICH-GCP. It is responsible for coordinating and challenging the various CROs/CMT members’ efforts and their functions related to the clinical trial to deliver quality trials within timelines and budget.
  • It is responsible for ensuring appropriate involvement of and communication with relevant stakeholders.
  • If assigned but not leading the trial, the role is to support and collaborate with the global CTM (Clinical Trial Manager) with the efficient planning, conducting and reporting of the trial.
  • The Clinical Trial Manager will ensure regular communication and agreement with global counterpart regarding strategy and execution of trials, including trouble shooting and functional support, as applicable.
  • It also acts as a functional leader for Japan and will also create corresponding strategy for the trial execution in alignment with Japan R&D and Global Clinical Operations, and other global teams (i.e. CDT), as applicable.
  • Collaborate cross-functionally with other R&D functions both at local and global level for clinical trials in Japan.

Requirments:

Moreover, you meet the following professional requirements:

  • A BSc or MSc level preferably within the medical, biological, pharmaceutical science or equivalent discipline
  • Minimum of 8 years of experience monitoring clinical trials. It would be even better to have experience in the oncology
  • Proven skills from working in a project oriented and international organization
  • Good oral and written communication skills
  • Ability to travel to field sites
  • Business level English in verbal, reading, & writing
  • Native level Japanese in verbal, reading, & writing

私たちは、社員ひとり一人が共通の目的に向かって、高い志を持ち、お互いを尊重し、共通の価値観をもとに日々仕事をしています。私たちの価値観の一つである誠実さを胸に、革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます。ジェンマブでは、がん患者さんの人生をより豊かにすることを目的に、部門や国境を超え、世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています。

互いを尊重して協力し合うチームワークは、ジェンマブの重要な企業文化であり、そのため世界中の社員が、インクルーシブ、オープン、協力しあう姿勢を大切に日々仕事をしています。地域、教育、文化、国籍、年齢、性別などを超えた多様性を推進し続けていくことが、企業が継続して成長していくために重要であると考えています。そのため採用においても、性別、年齢等に関わらず、スキルや能力をもとに多様性を重視し進めています。

ジェンマブ株式会社では、お客様の個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しております。ご応募いただく際は、個人情報の取扱いにご同意いただいた上、ご応募ください。

To apply for this job please visit genmab.wd3.myworkdayjobs.com.